Recurrent Acute Pancreatitis
Conditions
Keywords
Acute pancreatitis, ERCP, Sphincterotomy, Manometry, Sphincter of Oddi dysfunction
Brief summary
The therapeutic impact of ERCP with sphincterotomy in the management of patients with idiopathic recurrent acute pancreatitis (RAP) needs further study. The investigators conducted a single center, feasibility, randomized trial to determine 1) the role of pancreatic manometry in predicting future episodes of RAP and 2) differences in the efficacy of no, biliary (BES) or pancreatobiliary (dual) endoscopic sphincterotomy (DES).
Detailed description
Patients with idiopathic RAP, defined as ≥2 unexplained (per the treating physician) episodes of acute pancreatitis (based on standard criteria) requiring hospitalization, will be prospectively enrolled. All patients will undergo ERCP with manometry, with stratified randomization based on the assessment of pancreatic basal sphincter pressure. If \<40mmHg, the patient will be randomized to sham or biliary sphincterotomy (BES). If ≥40mmHg, the patient will be randomized to BES or pancreatobiliary (dual) sphincterotomy (DES). Patients and physicians will not be blinded to the assignment group. Patients will be followed for up to 10 years to determine 1) incidence of RAP requiring hospitalization (using standard definitions) or 2) interval development of chronic pancreatitis (CP). Differences between patients who did and did not develop RAP during follow-up will be compared to evaluate for factors associated with AP during follow-up.
Interventions
PROCEDUREBiliary sphincterotomy
Cutting of the biliary sphincter muscle.
PROCEDUREPancreatobiliary sphincterotomy
Cutting of both the biliary and pancreatic sphincter muscles.
PROCEDURESham
No sphincterotomy is performed in patients randomized to sham with normal SOM.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Idiopathic recurrent acute pancreatitis, defined as two or more episodes requiring hospitalization * ERCP with SOM planned
Exclusion criteria
* Chronic pancreatitis * Pancreas divisum * Alternate etiology identified (e.g., CBD stone, IPMN) * Inability to perform pancreatic manometry * Pregnancy, age \< 18, incarceration * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent acute pancreatitis | 120 months | Patients will be followed post-ERCP for up to 10 years. The primary outcome is development of acute pancreatitis following the index ERCP, based on standard definitions. Acute pancreatitis is defined as new onset of pancreatic-type abdominal pain with associated elevation in serum amylase or lipase \> 3 times the upper limit of normal, OR radiographic findings consistent with acute pancreatitis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interval development of chronic pancreatitis | 120 months | Determine the incidence of chronic pancreatitis during prolonged follow-up. Chronic pancreatitis is defined as characteristic changes on cross sectional imaging (CT or MRI/MRCP) or ERP (Cambridge classification). |
| Secondary assessment of risk factors for developing recurrent acute pancreatitis during follow-up | 120 months | A post hoc analysis will be conducted to evaluate for independent factors associated with having recurrent acute pancreatitis during follow-up |
Countries
United States
Outcome results
None listed